BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D
Received Mar 26, 2024 · Event occurred Feb 29, 2024
Report 1025402-2024-00005 · MDR key 18982239
Device
Generic name
Antisera, All Types, H. Influenza
Manufacturer
Lee Laboratories, Inc.Catalog number
227901
Lot number
3173176
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D THE USER RECEIVED WEAK AGGLUTINATION (FALSE POSITIVE RESULTS) FOR A PATIENT SAMPLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: NO RETURNS WERE RECEIVED FOR THIS COMPLAINT. THE CUSTOMER RETURNED TWO PHOTOS. AN ANALYSIS WAS PERFORMED ON EACH; THE FIRST PHOTO REVIEWED WAS A COMPARISON BETWEEN TWO DIFFERENT LOT OF HAEMOPHILUS INFLUENZAE TYPE D, WHICH SHOWED EVIDENCE OF THE QC SERUM PERFORMING AS EXPECTED. HOWEVER, THE SAME SERUM PRODUCED WEAK REACTIONS WITH PATIENT SAMPLES. THE SECOND PHOTO REVIEWED SHOWED THE EXTERIOR OF THE CARTON. TO INVESTIGATE THE COMPLAINT ON CATALOG 227901, LOT 3173176, A RETAINED SAMPLE OF THE COMPLAINT LOT WAS TESTED, ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, WITH AVAILABLE CULTURES REPRESENTING HAEMOPHILUS INFLUENZAE TYPE D. FOR EACH ANTISERUM TEST, A PORTION OF CULTURE WAS REMOVED FROM THE AGAR PLATE AND MIXED INTO ONE DROP OF ANTISERUM ON A SLIDE. IN ADDITION, EACH CULTURE WAS TESTED IN A DROP OF SALINE TO CHECK FOR ROUGHNESS. EACH SLIDE WAS ROTATED FOR 1 MINUTE BEFORE READING THE REACTION. RESULTS WERE AS FOLLOWS: 4+ REACTIONS WERE OBSERVED WITH THE RETAIN TESTED, WITH THE TYPE D CULTURES TESTED. NO REACTIVITY WAS OBSERVED WHEN THE CULTURES WERE TESTED IN SALINE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE TESTING PERFORMED. THE BATCH HISTORY RECORD FOR THE LOT WAS REVIEWED AND FOUND SATISFACTORY. COMPLAINTS FOR THE PRODUCT LINE WERE REVIEWED. THERE HAS BEEN ONE OTHER COMPLAINT IN THE THREE-YEAR PERIOD REVIEWED; BD WILL CONTINUE TO MONITOR FOR TRENDS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.
Additional Manufacturer Narrative
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D THE USER RECEIVED WEAK AGGLUTINATION (FALSE POSITIVE RESULTS) FOR A PATIENT SAMPLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.